A multicenter, randomized controlled trial of single and multiple dose regimes of oxfendazole for mild (one or two lesions) parenchymal brain cysticercosis

奥芬达唑单剂量和多剂量方案治疗轻度（一处或两处病变）脑实质囊尾蚴病的多中心、随机对照试验

• 批准号: 10704359
• 负责人: Hector Hugo Garcia
• 金额: $ 51.47万
• 依托单位: UNIVERSIDAD PERUANA CAYETANO HEREDIA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10704359
• 关键词: Aftercare; Albendazole; Antiparasitic Agents; Brain; Central Nervous System; Childhood; Cicatrix; Clinical; Clinical effectiveness; Cognitive deficits; Cohort Studies; Combined Modality Therapy; Cyst; DNA; Data; Developed Countries; Development; Diagnosis; Disease; Dose; Double-Blind Method; Early identification; Epilepsy; Evaluation; Future; Geographic Locations; Gliosis; Goals; Human; Image; Immigrant; India; Individual; Infection; Larva; Lesion; Leukocytes; Magnetic Resonance Imaging; Morbidity - disease rate; Names; Neurocysticercosis; Neurologic; Oral; Parasites; Peru; Population; Praziquantel; Principal Investigator; Prognosis; Publications; Quality of life; Radiology Specialty; Randomized, Controlled Trials; Regimen; Residual state; Resolution; Safety; Sampling; Seizures; Serum; Taenia solium; Testing; Urine; Ventricular; arm; calcification; cohort; comparative efficacy; diagnostic assay; efficacy evaluation; hippocampal atrophy; imaging biomarker; improved; long-term sequelae; magnetic resonance imaging biomarker; programs; response; safety assessment; tool; treatment choice

Oxfendazole in Neurocysticercosis Principal Investigator/Program Director: GARCIA, Hector H. A multicenter, randomized controlled trial of single and three-dose regimens of oxfendazole for mild (one or two lesions) parenchymal brain cysticercosis SUMMARY Taenia solium neurocysticercosis (NCC), the infection of the human central nervous system by the cystic larvae of Taenia solium, continues to be a major contributor to neurologic morbidity (particularly seizures and epilepsy) in most of the developing world, and a common diagnosis in immigrant populations in the USA and other industrialized countries. Anti-parasitic treatment destroys the brain cysts and improves the prognosis of the seizure disorder. The combination of albendazole (ABZ) plus praziquantel (PZQ) is more efficacious than ABZ alone in cases with multiple viable brain cysts, and recent publications also suggest increased efficacy in individuals with mild infections (one to two lesions, by far the most form of presentation in the Indian subcontinent, as well as in pediatric populations worldwide, in travelers to endemic regions, and in non-endemic regions such as the US). Still the efficacy of the best available regimens offer less than 70% efficacy in parenchymal brain NCC with one to two lesions. The recent development of oxfendazole (OXF) as a potential anti-parasitic agent for human use may provide a new, practical tool with increased efficacy and easier administration. We will perform a three-arm double blind, randomized controlled trial in six centers in two different geographic regions, three in India and three in Peru, to evaluate whether a single dose regime of OXF results in comparable efficacy to the currently used 10 day regime of ABZ plus PZQ, and also whether a 3-dose course of OXF can offer increased parasiticidal efficacy. The study cohort will also allow identification of early imaging markers that may predict lesion resolution in response to anti-parasitic treatment, and will provide additional data on the safety of oral OXF and factors associated to residual scarring, seizure relapses, or reduced quality of life in this population. Finally, systematic sampling in the cohort will provide defined batteries of DNA, white blood cells, serum and urine samples for future evaluation of diagnostic assays for single-lesion parenchymal NCC.

奥芬达唑治疗脑囊虫病首席研究员/项目主任：加西亚，赫克托·H。 单剂和三剂的多中心随机对照试验 奥芬达唑方案治疗轻度(一两个皮损) 实质性脑囊虫病 摘要 猪带绦虫脑囊虫病(NCC)，由囊虫感染人类中枢神经系统。 猪带绦虫幼虫仍然是神经系统发病率(特别是癫痫)的主要贡献者 和癫痫)，在大多数发展中国家，在移民人口中的一种常见诊断 美国和其他工业化国家。抗寄生虫治疗破坏脑囊肿，改善 癫痫发作障碍的预后。阿苯达唑(ABZ)+吡喹酮(PZQ)的联合用药更多 在患有多发性存活脑囊肿的病例中，ABZ比单独使用ABZ更有效，最近的出版物也表明 轻度感染患者的疗效增加(一到两个皮损，迄今为止最常见的 在印度次大陆以及世界各地的儿科人口中，在 在流行地区，以及在美国等非流行地区)。仍然是最好的药效 对于有一到两个病灶的实质性脑NCC，方案的有效率不到70%。最近的 奥芬达唑(Oxf)作为一种潜在的人类用抗寄生虫剂的开发可能提供一种新的， 实用工具，效率更高，管理更容易。我们将表演三臂双盲， 在两个不同地理区域的六个中心进行的随机对照试验，三个在印度，三个在印度 秘鲁，评估单剂量氧氟沙星方案是否产生与目前使用的疗效相当的效果 ABZ+PZQ的10天疗程，以及3剂疗程的Oxf是否可以提供更多的寄生虫杀伤力 功效。研究队列还将允许识别可能预测病变的早期成像标记 针对抗寄生虫治疗的决议，并将提供关于口服Oxf安全性的更多数据 以及与该人群中残留疤痕、癫痫复发或生活质量下降相关的因素。 最后，队列中的系统采样将提供确定的DNA、白细胞、血清 和尿样，以供将来对单发病灶实质性NCC的诊断试验进行评估。